U.S. patent number 5,064,059 [Application Number 07/650,518] was granted by the patent office on 1991-11-12 for dual container system with extractor for stopper.
This patent grant is currently assigned to Abbott Laboratories. Invention is credited to Sheldon M. Wecker, John S. Ziegler.
United States Patent |
5,064,059 |
Ziegler , et al. |
November 12, 1991 |
Dual container system with extractor for stopper
Abstract
Container systems employing a diluent container having an
extractor that is helically threaded and is used to engage a
resilient undercut vial stopper of an additive container.
Inventors: |
Ziegler; John S. (Arlington
Heights, IL), Wecker; Sheldon M. (Libertyville, IL) |
Assignee: |
Abbott Laboratories (Abbott
Park, IL)
|
Family
ID: |
24609258 |
Appl.
No.: |
07/650,518 |
Filed: |
February 5, 1991 |
Current U.S.
Class: |
206/221;
215/DIG.8; 215/364; 604/410; 215/356; 604/416 |
Current CPC
Class: |
B67D
7/0288 (20130101); A61J 1/2089 (20130101); A61J
1/2041 (20150501); Y10S 215/08 (20130101); A61J
1/10 (20130101); A61J 1/1475 (20130101) |
Current International
Class: |
B67D
5/02 (20060101); B67B 7/12 (20060101); B67D
5/01 (20060101); A61J 1/00 (20060101); B67B
7/00 (20060101); A61J 1/05 (20060101); B65D
051/00 (); A61M 005/14 () |
Field of
Search: |
;206/221
;215/356,364,DIG.8 ;604/410,416 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Price; William I.
Attorney, Agent or Firm: Trausch; A. Nicholas
Claims
I claim:
1. In combination, an extractor means for a flexible diluent
container and a removable resilient stopper for closing a second
engageable container;
said removable stopper having an undercut recess in an exposed end
of said stopper, said undercut recess comprising an entrance
opening having a first diameter and an undercut portion having a
second larger diameter;
said extractor means including an engagement portion protruding
along an axis for engaging said stopper within said undercut recess
for removal of the stopper from said second container when said
second container is engaged with said diluent container, said
engagement portion comprising helical threaded means having
tapering diametrical dimensions such that a leading end of said
helical threaded means has a diameter less than the first diameter
of said undercut recess and a following portion of said helical
threaded means has a diameter at least approximately equal to the
second diameter of said undercut recess.
2. The combination of claim 1 wherein said helical threaded means
extends from the leading end of said engagement portion a
predetermined length along the protruding axis.
3. The combination of claim 2 wherein the predetermined length of
the helical threaded means is the entire length of the protruding
axis.
4. The combination of claim 2 wherein said undercut portion of said
stopper has a predetermined axial depth.
5. The combination of claim 4 wherein said predetermined length of
said engagement portion is slightly greater than said predetermined
axial depth of said undercut portion.
6. The combination of claim 1 wherein said undercut recess of said
stopper has a threaded configuration and said entrance opening
diameter is the crest diameter of the thread and said undercut
portion diameter is the root diameter of the thread.
7. The combination of claim 6 wherein said threaded configuration
is tapered.
8. The combination of claim 7 wherein said helical threaded means
extends from the leading end of said engagement portion a
predetermined length along the protruding axis.
9. The combination of claim 8 wherein the predetermined length of
the helical threaded means is the entire length of the protruding
axis
10. The combination of claim 8 wherein said undercut portion of
said stopper has a predetermined axial depth.
11. The combination of claim 10 wherein said predetermined length
of said threads on said engagement portion is slightly greater than
said predetermined axial depth.
12. An extractor means for a flexible diluent container including
an access port having first means for engaging the removable
resilient stopper having an undercut recess in an exposed end of
said stopper, said undercut recess having an entrance opening
having a first diameter and an undercut portion having a second
diameter, said extractor means comprising an engagement portion
extending along a first axis for engaging said stopper within said
recess thereof, for removal of the stopper from such a second
container when engaged with said first means, wherein said
engagement portion comprises helical threaded means having tapering
diametrical dimensions such that a leading end of said helical
threaded means has a diameter less than the first diameter of said
undercut recess and a following portion of said helical threaded
means has a diameter at least approximately equal to the second
diameter of the undercut recess.
13. A removable resilient stopper for closing a vial or the like
having a threaded recess in an exposed end of said stopper wherein
said threads are tapered.
Description
BACKGROUND OF THE INVENTION
This invention relates to a dual container system such as a
medicament-containing vial and a fluid source such as a flexible
diluent container having associated means to effect sterile
intermixing of the contents of the two containers by external
manipulation after the containers are joined. More particularly,
the present invention relates to an improved extractor for the
flexible diluent container for use with a resilient undercut
stopper closing the vial or the like which enhances the mechanical
interlock between the vial stopper of the additive container and
the extractor of the flexible diluent container without increasing
the force necessary to engage the two containers. Thus the present
invention enhances the reliability of engagement and activation as
well as performs satisfactorily with a wide variety of stopper
materials of varying resilience.
In particular, this invention is for use in systems involving
packaging of a medicament and a diluent in separate containers
which may be connected to one another at the time of use for
convenient, safe mixing of the medicament and diluent in a sterile
environment. Such container systems are known in the art and
currently are sold by Abbott Laboratories of North Chicago, Ill.
under the trademark ADD-VANTAGE. A number of embodiments of such
systems are disclosed in U.S. Pat. No. 4,614,267 to Larkin, U.S.
Pat. No. 4,784,259 to Grabenkort, U.S. Pat. No. 4,614,515 to Tripp
and Larkin, and U.S. Pat. No. 4,784,658 to Grabenkort, all of which
are assigned to the assignee of this invention, and all of which
disclosures are hereby incorporated by reference.
In the noted system the flexible diluent container includes a
tubular port which provides a means for securing thereto a
stoppered medicament vial as well as a stopper removal means. The
stoppers each have an undercut or shouldered recess in their
exposed end. Previously the stopper removal means was composed of a
truncated cone or mushroom shaped engagement element or extractor
having a smooth surface and which is attached to a removable cover
that covers and seals the inner end of the port. As a stoppered
vial is advanced into and engaged with the port, normally by
threaded interengagement, the vial stopper advances onto the
extractor. The extractor thereby engages the stopper to
subsequently pull the stopper from the vial when the cover is
pulled from the port.
A wide variety of materials of varying hardness or resilience are
used to manufacture vial stoppers since governmental approval is
required for the type of material to be used with a particular
medicament. Stoppers made from softer materials are susceptible to
being pushed into the medicament vial during engagement by the
extractor. Alternatively the extractor may be pulled out of the
stopper during attempted extraction. Stoppers made from harder
materials are often more difficult to engage. Difficulty of
engagement between the vial stopper and port plug and in insuring
the subsequent withdrawal of the stopper also is due in part to the
wide variety of physical constructions of the outer surface of the
vial stoppers e.g., tapered or cylindrical. Of course, the axial
insertion force must be less than the force which will remove the
port plug from the port closing position.
It is highly desirable to provide a diluent container with a port
plug which will provide high reliability of engagement into the
stoppers of vials despite variations in materials and constructions
of those stoppers, to avoid pushing the stoppers into the vials and
assuring withdrawal of any stopper with the extractor, and which
will avoid pushing the cover off of the inner end of the port.
An important feature of this invention is that the extractor member
or port plug has a universal capability of functioning with vial
stoppers made from a wide variety of materials and in a wide
variety of constructions. It provides very high reliability of
engagement between the port plug of the flexible diluent container
and vial stopper of the additive medicament vial and of subsequent
withdrawal of the stopper.
It is therefore an object and advantage of the present invention to
afford a diluent container with a port plug which has the
aforementioned and other capabilities.
SUMMARY OF THE INVENTION
This invention relates to container systems employing a new
extractor for use with a resilient undercut stopper that closes the
open end of a vial or the like.
This invention relates to diluent containers with an improved
extractor so as to facilitate the intermating between the vial
stopper of the additive container and the extractor of the flexible
diluent container thus providing high reliability of engagement.
This is accomplished by a helically threaded extractor
configuration which mitigates the axial force transfer from the
extractor to the stopper during interengagement while preserving or
increasing the size of the engagement head and thus the amount of
force which can be transmitted from the extractor to the stopper
for removing the stopper. In this manner the port fluid seal and
vial stopper seal are maintained while the additive vial is engaged
into the port of the flexible diluent container and the vial
stopper becomes reliably engaged to the extractor of the flexible
diluent container. This, in turn, enables the user to manipulate
the bag and pull the stopper from the attached vial by pulling the
extractor inwardly off the port, thus resulting in the mixing of
the contents of the two compartments through the port. Normally
this involves dumping of the contents of the vial into the diluent
in the bag.
In a first configuration of this invention the medicament vial
typically is screwed into the port of the diluent container with
the recess of the vial stopper fitting over an engagement portion
of the extractor which is partially threaded. In doing so, the
helical threads of the extractor engage the constricted opening of
the stopper throat in a manner to enhance the axial mating
engagement therebetween and reduce axial resistance to passage of
the large plug head through the neck of the stopper recess. With
the helical threads of the port head having a lead greater than the
threads of the vial which engage the port, a positive axial drawing
action may be obtained so as to induce or "pull" the engagement
portion of the port plug into the recess of the stopper. Once the
extractor is fully seated, the shoulder at the base of the threads
of the extractor engages the inward side of the throat shoulder of
the stopper thus providing good gripping on the extractor when the
user wants to manipulate the bag and pull the extractor stopper
combination. The projecting threads also may remain in engagement
with the surrounding wall portions of the stopper or contribute to
the engagement on the throat shoulder.
In a second configuration of this invention, the recess of the vial
stopper is configured with threads complementary to the threads of
the extractor so as to further reduce axial resistance to passage
of the plug head into the stopper recess.
In a third configuration of this invention, the extractor is fully
threaded so as to make manufacturing easier besides other
advantages.
The present invention differs from previous threaded extractors or
port plug heads in that the thread depth and pitch are maximized,
allowing significant engagement in non-threaded as well as threaded
stoppers. Further the thread diameter preferably is tapered,
allowing the thread to start with little effort and then pulling
itself into the recessed stopper. Finally the leading flank of the
thread is relieved so as to reduce friction when the parts are
joined together.
One advantage of the present invention is that the tapered,
threaded extractor with a partial thread and a stem portion can be
used with the current non-threaded stoppers to facilitate an
eventual transition to threads on both parts.
Another advantage of the present invention is that the tapered,
threaded extractor is constructed so as to form and not cut threads
temporarily in the constricting opening of the current elastomeric
stoppers, thus facilitating entry with little effort and allowing
passage of larger extractor heads than could be pushed in axially.
A larger extractor provides more pulling force and greater
reliability for activation of the system.
The concaved leading flank and the narrow crest of the male thread
on the extractor reduces sliding friction during entry into the
stopper recess. Also the flat trailing flank of the threads applies
the maximum extraction force to the stopper.
The lead or axial travel per revolution of the threads on the
extractor head and in the threaded stopper is greater than that of
the vial and vial port threads. This draws the extractor head and
stopper together quickly, which ensures complete engagement and
neutralizes any initial compression which may develop before the
thread is engaged.
The engagement portion of the extractor is larger in the axial
direction than the axial length of the undercut portion of the
stopper recess. This stretches the stopper axially and constricts
it radially when the plug head bottoms out in the stopper recess.
Together with friction in the rotational direction, this tends to
break any adhesion which may have developed between the stopper and
vial, making the stopper subsequently easier to extract without
compromising the seal.
The tapered shape of the extractor head makes the stopper tend
toward the same outside taper when engaged, which also makes the
stopper easier to extract.
When a threaded stopper is used with a partially threaded or fully
threaded extractor, a greater extraction force can be
generated.
The fully threaded extractor, without the stem, allows for
simplification and greater fidelity in molding, since the extractor
head can be fully formed in an unscrewing mold component. The stem
of the partially threaded extractor can only be formed by mold
components which slide sideways, which increases mold complexity
and compromises the fidelity of the thread .
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view, partially in section, of a flexible diluent
container and an aligned additive medicament vial prior to
engagement and constructed according to a preferred embodiment of
the present invention;
FIG. 2 is an enlarged partial view similar to FIG. 1 as the vial is
being engaged with the flexible container;
FIG. 3 is a view similar to FIG. 2 showing the vial fully engaged
with the flexible container;
FIG. 4 is an enlarged view in section of the stopper shown in FIG.
1;
FIG. 5 is an enlarged side view of an extractor in current use with
the stopper of FIG. 4;
FIG. 6 is an enlarged view of the extractor depicted in FIG. 1 and
showing a preferred embodiment having a partially threaded engaging
portion according to the present invention;
FIG. 7 is an enlarged view partially in section of the extractor of
FIG. 6 engaged with the stopper of FIG. 4;
FIG. 8 is an enlarged view of an alternative stopper similar to
FIG. 4 but having a threaded recess according to a further
embodiment of the present invention; and
FIG. 9 is an enlarged view of an extractor similar to FIG. 6 but
showing a fully threaded engaging portion according to a further
embodiment of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Proceeding to a detailed description of the illustrated embodiment
of the invention, FIG. 1 illustrates an additive medicament vial 12
just prior to being secured to the flexible diluent container 14.
The diluent container typically is supplied with a protective cap
over the outer end of the port. See for example the closure
disclosed in U.S. Pat. No. 4,757,911 to Larkin, Tripp and Ziegler,
and assigned to the assignee of this invention, the disclosure of
which is hereby incorporated by reference. Such a closure is not
shown in FIG. 1, it being assumed that the port has been opened by
the health care technician in preparation for engagement of the
vial. As previously indicated, the additive medicament vial will be
supplied independently of the flexible container with the
interconnection being effected, for example, by the health care
technician. Typically the medicament vial is supplied with a
stopper 18 in the vial opening 20 and a removable cap (not shown)
covering the stopper for maintaining sterility as described in U.S.
Pat. No. 4,614,515. The cap is detached from a skirt member 22
which is circumscribed by a ring of ratchet teeth 24. A shroud 26
covers the lower portion of the vial. A label overlaps the skirt
and the shroud. The neck and discharge end portion 30 of the vial
is exposed for engagement with the diluent container by tearing off
the cap along an annular tear line, as described in U.S. Pat. No.
4,614,515. Once the caps are removed from the vial and from the
outer end of the port, the vial may be inserted into the port 32 of
the flexible container 14 with the ring of ratchet teeth 24
engaging complementary teeth 34 on the port to prevent easy removal
of the vial.
Vial 12 has the usual end portion 30 with external threads 36
extending therefrom. Complementary port threads 38 extend
internally from the port 32 which is mandrel sealed at 40 to the
walls of the flexible container 14. The stopper 18 is formed with a
undercut recess 44 with an annular lip or flange 46 defining an
entrance opening 48 of reduced diameter and an annular internal
shoulder 50 on its back or inward side defining the undercut recess
portion.
When it is desired to mix the contents 52 of a vial 12 into a
solution container 14, the caps are removed from the vial and from
the outer end of the port, and the vial and solution container
components are brought into mating alignment as in FIG. 1. Then the
vial 12 is screwed into port 32 resulting in the recess 44 of the
vial stopper 18 fitting over the engagement portion 54 of the port
plug 56. The contents of the vial 12 and the contents 58 of the
flexible container 14 may then be mixed by dumping the contents of
vial 12 into the container 14, by removing the port plug-engaged
stopper combination, 56 and 18. This is accomplished by manually
pulling on the rim 60 of the cover portion 62 of the plug by
manipulation from the exterior of the flexible bag 14, i.e.,
through the flexible container walls, as described further in the
aforementioned patents.
FIG. 2 is an enlarged partial view of the engagement of the vial
stopper 18 of the additive container and the extractor or port plug
56 of the flexible diluent container as the vial is being inserted
into the port 32. The stopper 18 of the vial 12 is mated onto the
engagement portion 54 of the port plug 56 as the vial is rotated
and advanced in effecting the threaded engagement of the end of the
vial 30 in the port 32 at threads 36 and 38. Helical threads 64 are
provided on the extractor or plug head 66 to engage the stopper
flange or lip 46 in the entrance opening 48 as the vial and its
stopper are rotated, thereby to induce the axial engagement of the
large plug head 66 into and through the smaller entrance opening 48
of the stopper recess. This reduces the axial forces that would
otherwise be transmitted to the stopper when thrusting the plug
head 66 through the entrance opening 48 of the stopper. Preferably
this inducement to mating engagement between the plug head and the
stopper is accomplished by the lead of the threads 64 being greater
than the lead of the threads 36 and 38 of the vial and the port 32.
This lead relationship tends to cause greater relative axial motion
between the engagement portion of the extractor 56 and the stopper
18 than is occurring by virtue of the threading of the vial 12 into
the port 32, thus tending to result in a drawing action between the
port plug 56 and the stopper 18.
The stopper is rotated onto the head 66 as the vial is rotated into
the threads 38 by virtue of the frictional engagement of the
stopper 18 in the vial opening 20. This insertion step is
illustrated in FIG. 2 where the leading edge of stopper 18 is
inserted approximately halfway into port 32. Once the vial stopper
is fully seated, as is shown in FIG. 3, the plug head 66 has fully
entered recess 44. The proximal or undercut shoulder 68 on the
engagement portion is disposed inward of the flange 46 and thus
provides good interference gripping on the lateral shoulder 50 of
the stopper when the user wants to manipulate the bag and pull the
port plug-stopper combination from the seated, sealing position of
FIG. 3. The extractor threads 64 further increase the effective
width of the shoulder 68, and may continue to be in an engaging
gripping relationship with the peripheral wall of the recess
36.
FIG. 4 depicts a sectional view of the stopper having an undercut
recess 44 currently in use. FIG. 5 depicts a vial port extractor
plug 70 also currently in use. During engagement of the vial and
the diluent container, the wings 72 of the plug 70 are axially
forced into engagement with the stopper 18.
FIGS. 6 depicts a side view of a threaded extractor according to a
preferred embodiment of the present invention. The extractor
includes a engagement portion 74 which is preferably tapered. The
engagement portion axially extends from the port internal cover 62
and includes helical threads 76. The threads have a flat trailing
flank 78 for maximizing extraction force on the stopper. The
relieved or concaved leading flank 80 and the narrow crest of the
thread 76 reduce sliding friction during relative motion with the
stopper. The diameter of the proximate (i.e. last) leading flank 82
is preferably equal to the diameter of the undercut recess portion
of the stopper, as shown in FIG. 7. The extractor of FIG. 6 also
includes a stem portion 84, the diameter of which is approximate
the diameter of the stopper opening 48. The engagement portion of
the extractor 74 and the stem portion 84 is larger in the axial
direction than the axial length of the undercut recess 44 of the
stopper. This stretches the stopper axially (as seen for example in
FIG. 7) which tends to break any adhesion which may have developed
between the stopper and vial, making the stopper easier to
extract.
FIG. 8 is an alternative stopper having a threaded recess. The root
diameter 86 of the female thread is undercut relative to the crest
diameter 88. The thread configuration is preferably tapered as
shown, although a straight untapered thread will also engage with
the male threads of the partial threaded extractor and stem of FIG.
7 or the fully threaded extractor of FIG. 9. A greater extraction
force can be generated when a threaded stopper is used with a
partially threaded or fully threaded extractor.
FIG. 9 depicts a fully threaded extractor without a stem that
allows for simplification and greater fidelity in the molding
process.
The engagement or extractor portion 74 of the extractor or port
plug 56 in FIG. 6 for example is tapered from a minimum diameter
smaller than the diameter of throat opening 48. When used with
stopper 18, this construction facilitates and eases the movement of
the head and threads 78 into and through the resilient opening 48
by pressing outward the engaged portion of lip 46. This enables
engagement portion 74 to easily enter recess 44 of the vial stopper
18. As noted above, the helical threads 76 then act to facilitate
and induce the movement of the tapered head 74 into the recess 44
as the vial is rotated and threaded into its seated position. The
lead of threads 76 should be approximately equal to or greater than
the lead of the vial and port threads 24 and 34 to avoid pushing
the stopper away from the engaging head 74 and back into the vial.
Preferably the lead of the threads 76 is substantial so as to gain
a relative drawing action between the engagement portion 74 and the
engaged portion of the stopper 18 as noted above. Such threading
engagement is particularly advantageous when the stopper 18 is
composed of relatively firm, less resilient materials. The outer
diameter dimension across the last following or proximal edges 82
of the helical threads 76 is approximately equal to or slightly
greater than the diameter at the shoulder 50 of the undercut
portion of the recess 44 as seen in FIG. 7. The stem portion 84 is
also undercut from the following edge 82 and has a diameter
approximate the entrance opening 48 of the stopper 18.
FIG. 6 further illustrates the disposition of the helical threads
76 and the taper and relief affected at their leading flanks 80 to
facilitate entry into the entrance opening 48. The threads also
have a narrow crest, as best seen in FIG. 6. A number of parameters
can be varied in regards to the construction of the port plug
including the number of helical threads, their pitch, diameter and
lead, and thus helical lead angle, and the diameter of the head 66
of the port plug itself.
A specific illustrative embodiment of a threaded port plug
constructed according to the present invention is the three lead
thread version as illustrated in FIGS. 6-9. Here the thread pitch
is 0.105" and the lead is 0.315". The major outside diameter of the
helical threads 64 starts at 0.402". Each trailing flank is flat
and is in a plane normal to the helical axis. Such a head is used
for engaging stoppers having a opening 48 about 0.282" in diameter,
a undercut recess 44 about 0.362" in diameter and a lip flange
about 0.100" thick in a vial having lead threads having a pitch of
0.125" and a lead of 0.250".
OPERATION
After the closure is removed from a diluent container 14 and the
end cap is removed from a selected vial 12, the vial is ready to be
inserted into the flexible container 14 as shown in FIG. 1. In this
position the medicament vial 12 is ready to be screwed into the
port 32. The interengagement of vial 12 and port 32 is accomplished
by threadable engagement of threads 36 with complementary threads
38 within port 32. Rotating vial 12 with respect to the flexible
container 14 causes end 30 to be drawn into port 32. This drawing
action causes engagement portion 54 of the port plug 56 to enter
the recess 44 in stopper 18 as well as effecting sealing engagement
of the vial with the port. As the vial 12 is screwed into port 32
and stopper 18 is rotated by the vial, the threads 64 on the
extractor or port plug 56 threadably engage the entrance opening of
the stopper to induce engagement of the stopper onto the extractor
and reduce the amount of axial insertion force otherwise imparted
to the stopper. When engagement portion 54 has completely entered
recess 44, the proximate flank 82 and the shoulder 50 fully and
positively engage the stopper. The ratchet teeth 24 engage the
compatible ratchet teeth 34 in the port thus preventing the vial 12
from being easily backed out of port 32 once interengagement has
begun. When the port plug 56 is fully seated as is shown in FIG. 3,
a great amount of force is required to disengage the port plug from
the stopper 18. This ensures that the stopper 18 will be removed
from the vial 12 when the extractor or port plug 56 is removed from
the port 32 by manually manipulating the cover 62 from the exterior
of the flexible container 14 without the stopper 18 and extractor
56 becoming disengaged from one another.
Such removal of the port plug 56 and stopper 18 combination will
create an open path through vial opening 20 for medicament 52 to
intermix with diluent 58. Diluent 58 and medicament 52 may be
further intermixed by squeezing the sides of the flexible container
14. The preferred material for the port plug is a polypropylene
copolymer.
The invention has been described as used in one particular system.
Activation of the drug delivery system including the mixing of the
medicament and diluent by removal of the port plug-stopper
combination may be readily accomplished by health care or pharmacy
personnel without the use of specially designed components or
sophisticated methods which require an excessive number of
procedures or prolonged exposure which might jeopardize sterility.
It will be appreciated that the invention may be embodied in other
similar systems.
The foregoing invention can now be practiced by those skilled in
the art. Such skilled persons will know that the invention is not
necessarily restricted to the particular embodiments presented
herein. The scope of the invention is to be defined by the terms of
the following claims as given meaning by the preceding
description.
* * * * *